CA2122207A1 - Procede et dispositif d'injection d'un liquide sterile et apyrogene obtenu par filtration - Google Patents

Procede et dispositif d'injection d'un liquide sterile et apyrogene obtenu par filtration

Info

Publication number
CA2122207A1
CA2122207A1 CA002122207A CA2122207A CA2122207A1 CA 2122207 A1 CA2122207 A1 CA 2122207A1 CA 002122207 A CA002122207 A CA 002122207A CA 2122207 A CA2122207 A CA 2122207A CA 2122207 A1 CA2122207 A1 CA 2122207A1
Authority
CA
Canada
Prior art keywords
liquid
filter
sterile
integrity
injection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002122207A
Other languages
English (en)
Other versions
CA2122207C (fr
Inventor
Laurent Simard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gambro Industries SAS
Original Assignee
Laurent Simard
Hospal Industrie
Gambro Industries
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laurent Simard, Hospal Industrie, Gambro Industries filed Critical Laurent Simard
Publication of CA2122207A1 publication Critical patent/CA2122207A1/fr
Application granted granted Critical
Publication of CA2122207C publication Critical patent/CA2122207C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
    • B01D65/10—Testing of membranes or membrane apparatus; Detecting or repairing leaks
    • B01D65/102—Detection of leaks in membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424—Substitution fluid path
    • A61M1/3437—Substitution fluid path downstream of the filter, e.g. post-dilution with filtrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • A61M1/3462—Circuits for the preparation thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • A61M1/3465—Substitution fluids using dialysate as substitution fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
    • B01D65/10—Testing of membranes or membrane apparatus; Detecting or repairing leaks
    • B01D65/104—Detection of leaks in membrane apparatus or modules
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/44—Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • C02F1/444—Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis by ultrafiltration or microfiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/17—General characteristics of the apparatus with redundant control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/705—Testing of filters for leaks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/707—Testing of filters for clogging

Abstract

Dispositif d'injection d'un liquide stérile et apyrogène obtenu par filtration et procédé de contrôle de l'intégrité du filtre utilisé à cette fin. Le dispositif d'injection d'un liquide stérile et apyrogène comprend : - au moins un filtre principal (15) ayant un premier et un second compartiments (16, 17) séparés par une membrane poreuse (18), le premier compartiment (16) ayant une entrée connectable à une source (11) de liquide à filtrer et le second compartiment (17) ayant une sortie connectée à une canalisation d'injection (22), - des moyens (23) pour faire circuler le liquide au travers du filtre principal (15) et dans la canalisation d'injection (22), et - des moyens (25, 26, 27) de vérification de l'intégrité du filtre principal comprenant : - un filtre secondaire (24) apte à retenir bactéries et éléments pyrogènes disposé sur la canalisation d'injection (22), et - des moyens (25, 26, 27) pour détecter un encrassement du filtre secondaire (24) pendant l'injection de liquide. L'invention trouve une application particulière dans le cas où le liquide injecté est du liquide de dialyse stérilisé en ligne pour être injecté en tant que liquide de substitution.
CA002122207A 1993-04-27 1994-04-26 Procede et dispositif d'injection d'un liquide sterile et apyrogene obtenu par filtration Expired - Fee Related CA2122207C (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9305198A FR2704432B1 (fr) 1993-04-27 1993-04-27 Dispositif d'injection de liquide dans un circuit extracorporel de sang.
FR9305198 1993-04-27

Publications (2)

Publication Number Publication Date
CA2122207A1 true CA2122207A1 (fr) 1994-10-28
CA2122207C CA2122207C (fr) 2007-04-03

Family

ID=9446658

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002122207A Expired - Fee Related CA2122207C (fr) 1993-04-27 1994-04-26 Procede et dispositif d'injection d'un liquide sterile et apyrogene obtenu par filtration

Country Status (10)

Country Link
US (1) US5476592A (fr)
EP (1) EP0622087B1 (fr)
JP (1) JP3553637B2 (fr)
CN (1) CN1117588C (fr)
AT (1) ATE157015T1 (fr)
CA (1) CA2122207C (fr)
DE (1) DE69405038T2 (fr)
ES (1) ES2107776T3 (fr)
FR (1) FR2704432B1 (fr)
WO (1) WO1994025085A1 (fr)

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FR2723002B1 (fr) * 1994-07-26 1996-09-06 Hospal Ind Dispositif et procede pour preparer un liquide de traitement par filtration
DE19607162C2 (de) * 1996-02-26 1998-01-15 Fresenius Ag Verwendung eines Dialysators mit zwei Modulen zur Durchführung eines Verfahrens zum Filtrieren und sofortigen Verwenden von Substituatflüssigkeit in einer Hämodialfiltrationsvorrichtung
DE19700466A1 (de) * 1997-01-09 1998-07-16 Polaschegg Hans Dietrich Dr Einrichtung und Verfahren zur Hämodiafiltration
JP4416368B2 (ja) * 1997-02-14 2010-02-17 ネクステージ メディカル インコーポレイテッド カートリッジ内に配置された体外流体流パネルを使用する流体処理装置及び方法
US6852090B2 (en) 1997-02-14 2005-02-08 Nxstage Medical, Inc. Fluid processing systems and methods using extracorporeal fluid flow panels oriented within a cartridge
CA2338952C (fr) * 1998-07-31 2007-04-03 Nephros, Inc. Procede efficace d'hemodiafiltration
JP4436569B2 (ja) 1998-10-30 2010-03-24 ネフロス・インコーポレーテッド 浸透圧差による透過型濾過システム
FR2791574B1 (fr) * 1999-03-30 2002-06-14 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
FR2791576B1 (fr) * 1999-03-30 2002-06-14 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
JP2002539930A (ja) * 1999-03-30 2002-11-26 ガンブロ ルンデイア アクチーボラグ 熱に敏感な流体を滅菌するための方法および装置
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FR2791575B1 (fr) * 1999-03-30 2002-06-28 Hospal Ind Procede et dispositif pour steriliser et dispenser un liquide a usage medical
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US6635026B1 (en) 1999-11-08 2003-10-21 Hospal Industrie Haemofiltration machine for independently controlling the concentration of a least two ionic substances in a patient's internal medium
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US6716356B2 (en) 2000-01-11 2004-04-06 Nephros, Inc. Thermally enhanced dialysis/diafiltration system
EA004446B1 (ru) 2000-10-30 2004-04-29 Нефрос, Инк. Двухступенчатый фильтровальный картридж
WO2002062454A1 (fr) * 2001-02-07 2002-08-15 Nephros, Inc. Methode et appareil pour module d'hemodiafiltration
US6649063B2 (en) * 2001-07-12 2003-11-18 Nxstage Medical, Inc. Method for performing renal replacement therapy including producing sterile replacement fluid in a renal replacement therapy unit
US7112273B2 (en) * 2002-09-27 2006-09-26 Nxstage Medical, Inc. Volumetric fluid balance control for extracorporeal blood treatment
US7686778B2 (en) * 2003-01-15 2010-03-30 Nxstage Medical, Inc. Waste balancing for extracorporeal blood treatment systems
US8235931B2 (en) 2003-01-15 2012-08-07 Nxstage Medical, Inc. Waste balancing for extracorporeal blood treatment systems
ES2346669T5 (es) * 2005-07-01 2020-03-18 Gambro Lundia Ab Aparato para verificar un filtro
US7534349B2 (en) * 2005-09-02 2009-05-19 Nephros, Inc. Dual stage ultrafilter devices in the form of portable filter devices, shower devices, and hydration packs
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Also Published As

Publication number Publication date
CN1117588C (zh) 2003-08-13
JP3553637B2 (ja) 2004-08-11
FR2704432A1 (fr) 1994-11-04
DE69405038T2 (de) 1998-02-26
CA2122207C (fr) 2007-04-03
EP0622087A1 (fr) 1994-11-02
DE69405038D1 (de) 1997-09-25
US5476592A (en) 1995-12-19
EP0622087B1 (fr) 1997-08-20
ES2107776T3 (es) 1997-12-01
WO1994025085A1 (fr) 1994-11-10
FR2704432B1 (fr) 1995-06-23
ATE157015T1 (de) 1997-09-15
CN1108028A (zh) 1995-09-06
JPH078553A (ja) 1995-01-13

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Effective date: 20130426